STIMULATION SYSTEM WITH PERCUTANEOUSLY DELIVERABLE PADDLE LEAD AND METHODS OF MAKING AND USING

• US 20090270957A1
• Filed: 04/23/2009
• Published: 10/29/2009
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Krueger, Joel Adam, Pianca, Anne Margaret, Gould, Christopher B.
• Granted Patent: US 9,492,655 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

An implantable lead includes an expandable paddle body and a plurality of electrodes disposed on the paddle body. The electrodes are configured and arranged to provide electrical stimulation to adjacent tissue when implanted and the lead is coupled to a control module. The paddle body is configured for percutaneous implantation through an introducer followed by expansion of a volume of the paddle body by at least 10%. Alternatively, the paddle body is configured for percutaneous implantation and when implanted the lead is configured and arranged so that a position or orientation of the plurality of electrodes relative to the paddle body can be altered.

Claims

1. An implantable lead, comprising:

an expandable paddle body, wherein the paddle body is configured for percutaneous implantation through an introducer followed by expansion of a volume of the paddle body by at least 10%; and

a plurality of electrodes disposed on the paddle body and configured and arranged to provide electrical stimulation to adjacent tissue when implanted and the lead is coupled to a control module.

2. The implantable lead of claim 1, wherein the paddle body comprises an expandable mesh.

3. The implantable lead of claim 1, wherein the paddle body is configured and arranged for expansion by inserting a fluid into the paddle body.

4. The implantable lead of claim 3, wherein the paddle body is configured and arranged for deflation over a period of time after expansion.

5. The implantable lead of claim 1, wherein at least one of the electrodes has an identification feature to allow determination of an orientation of implantation of the lead by observation of the identification feature.

6. The implantable lead of claim 5, wherein the identification feature is a shape of the at least one electrode.

7. A kit for implanting a lead, comprising:

the implantable lead of claim 1; and

an introducer through which the paddle body of the lead can be percutaneously implanted into tissue of a body.

8. The kit of claim 7, wherein the introducer comprises a plurality of windows through which, when inserted into tissue, at least one of the electrodes of the implantable lead can be used to stimulate the tissue while still disposed within the introducer.

9. A kit for implanting a lead, comprising:

a lead comprising a paddle body with a plurality of electrodes disposed on the paddle body; and

an introducer with a non-circular, closed-path, transverse cross-section through which the paddle body of the lead can be percutaneously implanted into tissue of a body.

10. The kit of claim 9, wherein the introducer comprises a plurality of windows through which, when inserted into tissue, at least one of the electrodes of the implantable lead can be used to stimulate the tissue while still disposed within the insertion needle.

11. The kit of claim 9, wherein at least one of the electrodes has an identification feature to allow determination of an orientation of implantation of the lead by observation of the identification feature.

12. The kit of claim 11, wherein the identification feature is a shape of the at least one electrode.

13. An implantable lead, comprising:

a paddle body, wherein the paddle body is configured for percutaneous implantation and when implanted the lead is configured and arranged so that a position or orientation of the plurality of electrodes relative to the paddle body can be altered; and

a plurality of electrodes disposed on the paddle body and configured and arranged to provide electrical stimulation to adjacent tissue when implanted and the lead is coupled to a control module.

14. The implantable lead of claim 13, wherein the plurality of electrodes are each coupled to a hinge that allows the electrode to change position or orientation.

15. A method for percutaneous implantation of a lead of an electrical stimulation system, the method comprising:

inserting an introducer through skin of a patient with at least a portion of the lead disposed in the introducer, the lead comprising a paddle body with a plurality of electrodes disposed on the paddle body;

positioning the lead near the tissue to be stimulated;

withdrawing the introducer leaving the lead implanted in the patient; and

expanding a volume of the paddle body by at least 10% after implanting the lead.

16. The method of claim 15, wherein expanding the paddle body comprises introducing a fluid into the paddle body.

17. The method of claim 15, further comprising deflating the paddle body after a period of time has elapsed from expanding the paddle body.

18. The method of claim 15, wherein positioning the lead comprises observing an identification feature on at least one of the electrodes to determine an orientation of implantation of the lead.

19. The method of claim 15, wherein positioning the lead comprises stimulating tissue through windows in the introducer using electrodes on the lead.

20. The method of claim 15, wherein the needle introducer has a non-circular, closed-path, transverse cross-section through which the paddle body of the lead can be percutaneously implanted into tissue of a body.